Prescription medication · Opioid / Norepinephrine Reuptake Inhibitor
tapentadol
Also sold as Nucynta. Nucynta is used to manage acute pain in adults and children (6 years and older weighing at least 88 pounds).
Data updated 2026-05-15
- 33,054
- FDA reportsModerately reported
- 16
- InteractionsSeveral interactions
- $15.80
- Brand price (NADAC)
What the data shows
tapentadol (Nucynta) is a prescription Opioid / Norepinephrine Reuptake Inhibitor, reported at a middle-of-the-pack volume (33,054 FDA reports), with 16 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
tapentadol (Nucynta) is a prescription Opioid / Norepinephrine Reuptake Inhibitor. Nucynta is used to manage acute pain in adults and children (6 years and older weighing at least 88 pounds).
Nucynta is a strong pain medicine. It is used to treat severe acute pain when other pain medicines are not strong enough.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$15.80/unit
Generic Available
Yes (1 manufacturer)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Nucynta is used to manage acute pain in adults and children (6 years and older weighing at least 88 pounds).
Common side effects
Feeling sick to your stomach (nausea), Feeling dizzy, Throwing up (vomiting)
Key warnings
Nucynta can cause addiction, abuse, and misuse, which can lead to overdose and death.
The sections below are summarized in plain English from tapentadol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Nucynta works in two ways to relieve pain. It acts on opioid receptors in the brain to reduce pain signals. It also prevents the reuptake of norepinephrine, which can also help reduce pain.
Side Effects (from patient reports)
Based on 33,054 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for tapentadol, by number of reports
- Death
Death
11,641 reports
- Toxicity To Various Agents
Toxicity To Various Agents
9,719 reports
- Overdose
Overdose
5,886 reports
- Drug Abuse 1,549
Drug Abuse
1,549 reports
- Drug Dependence 1,063
Drug Dependence
1,063 reports
- Drug Withdrawal Syndrome Neonatal 944
Drug Withdrawal Syndrome Neonatal
944 reports
- Pain 743
Pain
743 reports
- Nausea 713
Nausea
713 reports
- Accidental Overdose 705
Accidental Overdose
705 reports
- Fatigue 433
Fatigue
433 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for tapentadol each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where tapentadol sits
tapentadol has more FDA adverse-event reports than 66% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is tapentadol; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 33,054 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2005–2025.
Total Reports
33,054
Reports Mentioning Death
20,529
62.1% of reports — not proof of cause
Hospitalization Reports
4,458
Top Indication
Pain
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DEATH | 11,641 |
| 2 | TOXICITY TO VARIOUS AGENTS | 9,719 |
| 3 | OVERDOSE | 5,886 |
| 4 | DRUG ABUSE | 1,549 |
| 5 | DRUG DEPENDENCE | 1,063 |
| 7 | DRUG WITHDRAWAL SYNDROME NEONATAL | 944 |
| 8 | PAIN | 743 |
| 9 | NAUSEA | 713 |
| 10 | ACCIDENTAL OVERDOSE | 705 |
| 11 | FATIGUE | 433 |
| 12 | HEADACHE | 408 |
| 13 | DIZZINESS | 403 |
| 14 | INTENTIONAL PRODUCT MISUSE | 398 |
| 15 | SOMNOLENCE | 386 |
| 16 | VOMITING | 382 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Nucynta can cause addiction, abuse, and misuse, which can lead to overdose and death. Your doctor will check your risk before prescribing and regularly during treatment. This medicine can also cause life-threatening breathing problems, especially when you start taking it or after a dose increase. Taking Nucynta with benzodiazepines (like Xanax or Valium), alcohol, or other CNS depressants can cause sleepiness, slowed breathing, coma, and death. Accidental ingestion, especially by children, can cause a fatal overdose. If you are pregnant and use Nucynta for a long time, your baby could have withdrawal symptoms after birth.
Known Drug Interactions
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and...
Mechanism: Taking these drugs together increases the risk of dangerous slowing of your breathing. They can also cause a serious buildup of a brain chemical called serotonin.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and...
Mechanism: Both of these medications can slow down your breathing and affect your brain's serotonin levels. Combining them makes these side effects more likely and more severe.
Product Clinical Comment on Concomitant Use [See Contraindications (4.1)] ; Predominant Effect/Risk [Hypertensive Reaction (HR) [See Warnings and Precautions (5.3)] ; or Serotonin Syndrome (SS) [See Warnings and Precautions (5.7)] ] Altretamine Use with caution If not otherwise specified in this table, consider avoiding concomitant use (see also information on medication-free intervals , use agent at the lowest appropriate dose, monitor for effects of the interaction, advise the patient to report potential effects, and be prepared to discontinue the agent and treat effects of the...
Mechanism: Combining these can lead to a toxic level of serotonin or a sudden rise in blood pressure. Both drugs increase chemicals in your system that can cause these serious side effects.
Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol.
Mechanism: Both drugs are sedatives that slow down your brain and nervous system. Taking them together can make you feel very sleepy or make it hard to breathe.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Mechanism: Both medications increase a brain chemical called serotonin. If serotonin levels get too high, it can cause a serious medical problem called serotonin syndrome.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I stop taking Nucynta suddenly?
Can Nucynta cause constipation?
Is Nucynta a strong painkiller?
Can I drink alcohol while taking Nucynta?
What should I do if I think I have taken too much Nucynta?
Can Nucynta make me feel sleepy?
Will Nucynta interact with my other medications?
How often can I take Nucynta?
Can Nucynta be used for long-term pain?
Is Nucynta addictive?
What are the common side effects of tapentadol?
Does tapentadol interact with other medications?
What drug class is tapentadol?
What pregnancy or breastfeeding source fields are listed for tapentadol?
Related Medications in Opioid / Norepinephrine Reuptake Inhibitor
Other drugs grouped near tapentadol - same-class peers and common alternatives.
abatacept
Orencia
Orencia is a medicine that helps to reduce inflammation.
Compare with tapentadol →
acetaminophen
Tylenol
Acetaminophen (Tylenol) is a medicine that can relieve pain and reduce fever.
Compare with tapentadol →
acetaminophen/hydrocodone
Vicodin, Norco
This medicine contains acetaminophen and hydrocodone.
Compare with tapentadol →
acetaminophen/oxycodone
Percocet
Percocet is a strong pain medicine.
Compare with tapentadol →
adalimumab
Humira
Idacio is a medicine that blocks a protein called TNF.
Compare with tapentadol →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for tapentadol: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 33,054.
- clarithromycin Δ 193 reports · Macrolide Antibiotic 33,247reports
- paroxetine Δ 388 reports · Selective Serotonin Reuptake Inhibitor (SSRI) 32,666reports
- candesartan Δ 423 reports · Angiotensin II Receptor Blocker (ARB) 33,477reports
- telmisartan Δ 557 reports · Angiotensin II Receptor Blocker (ARB) 33,611reports
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 62.11%.
- anidulafungin Δ 18.56 pts · 1,527 reports · Echinocandin Antifungal 43.55%death share
- phenylephrine Δ 20.16 pts · 3,669 reports · Alpha-1 Agonist 41.95%death share
- vasopressin Δ 22.62 pts · 4,135 reports · Vasopressin Receptor Agonist 39.49%death share
- dobutamine Δ 23.81 pts · 3,554 reports · Inotropic Agent (Beta-1 Agonist) 38.29%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on tapentadol
Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.
Disclosure: This link may earn us a commission at no extra cost to you. See our terms.
What the FDA Data Shows for tapentadol
The FDA label for tapentadol (sold under brand names such as Nucynta) classifies it as a prescription-only medication in the Opioid / Norepinephrine Reuptake Inhibitor class. Nucynta is used to manage acute pain in adults and children (6 years and older weighing at least 88 pounds). Official labeling lists 4 commonly reported side effects, including Feeling sick to your stomach (nausea), Feeling dizzy, Throwing up (vomiting).
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 33,054 voluntary reports. The database also lists 16 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: December 30, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages